India, Jan. 8 -- Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of DYANAVEL XR.
The FDA has determined that the ANDA is eligible for 180-day exclusivity, underscoring Granules' growing strength in the development and commercialization of complex and differentiated generics for the US market. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and addresses an estimated market opportunity of USD 41 million.
Earlier, on...